ROYCEDERM SEBORRHEIC DERMATITIS AND DANDRUFF MEDICATED CLEANSING BAR- pyrithione zinc 2% soap

RoyceDerm Seborrheic Dermatitis and Dandruff Medicated Cleansing Bar by

Drug Labeling and Warnings

RoyceDerm Seborrheic Dermatitis and Dandruff Medicated Cleansing Bar by is a Otc medication manufactured, distributed, or labeled by RoyceDerm LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Pyrithione Zinc 2%

PURPOSE

• Anti-dandruff
• Anti-seborrheic dermatitis

DOSAGE & ADMINISTRATION

Controls and reduces the symptoms of dandruff and seborrheic dermatitis

WARNINGS

For external use only

you have a conditionthat covers a large area of the body.

avoid contact with eyesIf contact occurs, rinse thoroughly with water.

if condition worsensor does not improve.

ask a healthprofessional before use.

In case of accidental ingestion, seek medical advice immediately or contact a Poison Control Center right away.(1-800-222-1222)

INDICATIONS & USAGE

• Cleanse and dry skin.
• Apply a thin layer to affected areas.
• Use thricedaily or as directed by a doctor.

OTHER SAFETY INFORMATION

store at room temperature.

INACTIVE INGREDIENT

Tetrasodium EDTA, Sodium Cocoyl Isethionate, Glycerin, Polyquaternium-7, Menthol, Adep Bovis, Olea Europaea(Olive) fruit Oil, Butyrospermum Parkii (Shea Butter)

QUESTIONS

Email service@roycederm.com

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ROYCEDERM SEBORRHEIC DERMATITIS AND DANDRUFF MEDICATED CLEANSING BAR 
pyrithione zinc 2% soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85424-008
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5)	PYRITHIONE ZINC	4.52 g  in 226 g

Inactive Ingredients
Ingredient Name	Strength
BUTYROSPERMUM PARKII (SHEA) BUTTER (UNII: K49155WL9Y)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM COCOYL ISETHIONATE (UNII: 518XTE8493)
POLYQUATERNIUM-7 (UNII: 0L414VCS5Y)
MENTHOL (UNII: L7T10EIP3A)
TETRASODIUM EDTA (UNII: MP1J8420LU)
ADEPS BOVIS (UNII: 98HPY76U4W)
OLEA EUROPAEA (OLIVE) FRUIT OIL (UNII: 6UYK2W1W1E)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85424-008-01	226 g in 1 CARTON; Type 0: Not a Combination Product	08/31/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M032	08/31/2025

Labeler - RoyceDerm LLC (130329531)